Fludarabine exposure in patients undergoing Fludarabine based lymphodepletion prior to CAR-T cell therapy

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-524278-40-00

Enrollment

Registered

2026-03-23

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients undergoing Fludarabine based lymphodepletion prior to CAR-T cell therapy, for hematological malignancy

Brief summary

Area under concentration time curve (AUC) of F-Ara-A from time 0 to infinity, Coefficient of variation (CV) for plasma concentrations of F-Ara-A, Maximum observed concentration (Cmax)

Detailed description

Patient covariates: - Sex - Creatinine - Creatinine clearance - Cystatine C - Cystatine C clearance - Actual body weight (ABW) - Ideal body weight (IBW) - Body mass index (BMI) - Body surface aera (BSA); To be assessed after the last included patient has finished LDC.

Interventions

DRUGKymriah 1.2 x 10^6 – 6 x 10^8 cells dispersion for infusion

DRUGEndoxan 500 mg

DRUGpoeder voor oplossing voor injectie

DRUGFludarabine Teva 25 mg/ml solution à diluer pour injection ou perfusion

DRUGFLUDARABINE TEVA 25 mg/ml KONZENTRAT ZUR HERSTELLUNG EINER INJEKTIONS- ODER INFUSIONSLOESUNG

DRUGYESCARTA 0.4 – 2 x 10e8 cells dispersion for infusion

DRUGEndoxan 1000 mg

DRUGFludarabine Teva 25 mg/ml concentraat voor oplossing voor injectie of infusie

DRUGTecartus 0.4 - 2 x 10e8 cells dispersion for infusion

DRUGCARVYKTI 3.2 × 10^6 – 1 × 10^8 cells dispersion for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Area under concentration time curve (AUC) of F-Ara-A from time 0 to infinity, Coefficient of variation (CV) for plasma concentrations of F-Ara-A, Maximum observed concentration (Cmax)	—

Secondary

Measure	Time frame
Patient covariates: - Sex - Creatinine - Creatinine clearance - Cystatine C - Cystatine C clearance - Actual body weight (ABW) - Ideal body weight (IBW) - Body mass index (BMI) - Body surface aera (BSA); To be assessed after the last included patient has finished LDC.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 24, 2026